IEEM-Heat and Heart Failure
- Conditions
- Heart FailureHyperthermia
- Registration Number
- NCT06961929
- Lead Sponsor
- University of Texas Southwestern Medical Center
- Brief Summary
We will test the hypothesis that increasing skin wetness, and thus evaporative cooling, will attenuate the increase in core body temperature and accompanying cardiac stress during heat wave conditions in individuals with congestive heart failure. Secondly, we propose that fan use alone may be possibly detrimental (very hot and dry) depending on the environmental conditions. To accomplish these objectives, individuals with congestive heart failure and otherwise healthy control individuals will be exposed to the simulated heat wave condition (very hot and dry) with the following cooling modalities: A) control trial (no fan or skin wetting), B) skin wetting only trial, and C) fan only trial in a randomized crossover fashion. Thermoregulatory and cardiovascular responses will be evaluated throughout these simulated heat wave exposures.
Primary outcomes variables will be skin and core temperatures, while secondary variables will include measures of cardiovascular stress, myocardial perfusion, heart rate, and echo-based measures of cardiac function.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 88
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Change in Core Body Temperature in Fan Trial Prior to and after each simulated heat wave exposure (approximately 180 minutes.) Core body temperature will be measured from gastrointestinal temperature via an ingestible telemetric pill or rectal temperature via telemetric pill suppository or rectal thermistor. Core body temperature will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those temperatures will reflect the change in core body temperature.
Change in Core Body Temperature in Skin-Wetting Trial Prior to and after each simulated heat wave exposure (approximately 180 minutes.) Core body temperature will be measured from gastrointestinal temperature via an ingestible telemetric pill or rectal temperature via telemetric pill suppository or rectal thermistor. Core body temperature will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those temperatures will reflect the change in core body temperature.
Change in Core Body Temperature in Control Trial Prior to and after each simulated heat wave exposure (approximately 180 minutes.) Core body temperature will be measured from gastrointestinal temperature via an ingestible telemetric pill or rectal temperature via telemetric pill suppository or rectal thermistor. Core body temperature will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those temperatures will reflect the change in core body temperature.
Change in Skin Temperature in Fan Trial Prior to and after each simulated heat wave exposure (approximately 180 minutes.) Skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin. Skin temperature will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those temperatures will reflect the change in skin temperature.
Change in Skin Temperature in Skin-Wetting Trial Prior to and after each simulated heat wave exposure (approximately 180 minutes.) Skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin. Skin temperature will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those temperatures will reflect the change in skin temperature.
Change in Skin Temperature in Control Trial Prior to and after each simulated heat wave exposure (approximately 180 minutes.) Skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin. Skin temperature will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those temperatures will reflect the change in skin temperature.
- Secondary Outcome Measures
Name Time Method Change in Cardiac Output in Skin-Wetting Trial Prior to and after each simulated heat wave exposure (approximately 180 minutes.) Cardiac output (how much blood is ejected from the heart) will be measured using echocardiography. Cardiac output will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those heart rates will reflect the change in cardiac output.
Cardiac Output in Control Trial Prior to and after each simulated heat wave exposure (approximately 180 minutes.) Cardiac output (how much blood is ejected from the heart) will be measured using echocardiography. Cardiac output will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those heart rates will reflect the change in cardiac output.
Change in Cardiac Output in Fan Trial Prior to and after each simulated heat wave exposure (approximately 180 minutes.) Cardiac output (how much blood is ejected from the heart) will be measured using echocardiography. Cardiac output will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those heart rates will reflect the change in cardiac output.
Change in Heart Rate in Fan Trial Prior to and after each simulated heat wave exposure (approximately 180 minutes.) Heart rate will be measured from ECG electrodes attached to the participant. Heart rate will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those heart rates will reflect the change in heart rate.
Change in Heart Rate in Skin-Wetting Trial Prior to and after each simulated heat wave exposure (approximately 180 minutes.) Heart rate will be measured from ECG electrodes attached to the participant. Heart rate will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those heart rates will reflect the change in heart rate.
Change in Heart Rate in Control Trial Prior to and after each simulated heat wave exposure (approximately 180 minutes.) Heart rate will be measured from ECG electrodes attached to the participant. Heart rate will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those heart rates will reflect the change in heart rate.
Rate Pressure Product in Fan Trial At the end of each heat wave exposure. Approximately 180 minutes after the start of the heat wave simulation. Rate Pressure Product is calculated by multiplying Systolic Blood Pressure and Heart Rate.
Rate Pressure Product in Skin-Wetting Trial At the end of each heat wave exposure. Approximately 180 minutes after the start of the heat wave simulation. Rate Pressure Product is calculated by multiplying Systolic Blood Pressure and Heart Rate.
Rate Pressure Product in Control Trial At the end of each heat wave exposure. Approximately 180 minutes after the start of the heat wave simulation. Rate Pressure Product is calculated by multiplying Systolic Blood Pressure and Heart Rate.